For Breast Cancer,FDA Clears Stereotactic Radiotherapy System

A new noninvasive stereotactic radiotherapy system (GammaPod, Xcision Medical Systems, LLC) intended for use in treating cancer in breast tissue has received FDA approval.

Robert Ochs, Ph.D., acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said, “Patients will approach a treatment option that gives more prominent accuracy in delivering radiation treatment to breast tumors while saving surrounding breast tissue”.

Radiation treatment is an important treatment option for cancer patients. Approximately 60% of all cancer patients will be treated with some type of radiation treatment. During radiation treatment, tumor cells are killed when their DNA is harmed by the radiation being absorbed into them.

While radiation treatment has the potential to kill tumor cells, it can also damage healthy tissue around the tumor. For the noninvasive stereotactic delivery of a radiation dose the GammaPod system is used to a portion (partial volume) of the breast in conjunction with breast-conserving treatment.

During the procedure, radiation is delivered to specific areas of the breast. The GammaPod has not been appeared to be as effective as entire breast radiation treatment (WBRT) and isn’t intended to replace WBRT.

GammaPod utilizes a large number of focused beams of radiation from 36 rotating radioactive Cobalt-60 sources in combination with a two-layer, vacuum- assisted cup that immobilizes the breast to achieve a more accurate delivery of radiation.

During treatment gives the advantage of minimizing the radiation dose the GammaPod design to immobilize the breast to the surrounding healthy tissues in the breast, heart, and lungs. For this clearance, the FDA checked the scientific evidence, including a clinical study of 17 patients that tested the feasibility of accurately delivering the recommended dose to the breast tumor while limiting radiation to the healthy tissue.

To the breast tumor, the clinical evidence supports delivering the recommended dosage with minimal radiation-induced side effects, for example, skin redness or erythema. The GammaPod system was reviewed into through the pre-market notice 510(k) pathway.

A 510(k) is a premarket submission made by device manufacturers to the FDA to show that the new device is substantially comparable to a legally marketed predicate device.


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